BEUDAMED
    FDA Adverse Event Summary report: N

    INTERGARD ULTRA THIN KNITTED VASCULAR PROSTHESES

    MDR report key: 272301 · Received March 28, 2000

    Report

    Report Number
    1640201-2000-00009
    Date Received
    March 28, 2000
    Date of Event
    February 10, 2000
    Report Date
    February 16, 2000
    Manufacturer
    INTERVASCULAR, SAS
    Product Code
    DSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH THREE VASCULAR PROSTHESES: TWO INTERVASCULAR INTERGARD PROSTHESES AND ONE VASCUTEK GRAFT FOR WHICH VERY LIMITED INFO WAS PROVIDED. INTERGARD PROSTHESES WERE INPLANTED IN REPLACEMENT OF THE TWO RENAL ARTERIES. THE VASCUTEK GRAFT WAS IMPLANTED IN AORTIC POSITION. AT THE TIME OF IMPLANTATION, PHYSICIAN SOAKED THE GRAFT IN SALINE SOLUTION AND NOTICED FOAM OR BUBBLES IN THE SALINE SOLUTION. NOTE THAT GRAFT SOAKING IS NOT PROVIDED IN INTERVASCULAR PRODUCT INSTRUCTIONS FOR USE. NOTE ALSO THAT THIS IS THE FIRST TIME THAT SUCH AN EVENT HAS BEEN REPORTED TO INTERVASCULAR. AFTER IMPLANTATION, PT HAD A RENAL INSUFFICIENCY WHICH IS NOT UNEXPECTED IN THIS TYPE OF VASCULAR SURGERY AND UNDERWENT DIALYSIS. IT SHOULD BE NOTED THAT AS OF TODAY THE PT LEFT THE HOSP AND NO ADDITIONAL COMPLICATIONS HAS BEEN REPORTED. IN SUMMARY, PHYSICIAN SOAKED THE GRAFT IN A SALINE SOLUTION WHICH WAS CONTRARY TO INSTRUCTIONS FOR USE AND NOTICED FOAM/BUBBLES. THERE IS NO MENTION OF ANY SOAKING IN THE INSTRUCTIONS FOR USE. INTERVASCULAR HAS NO UNDERSTANDING OF THE EFFECT OF SUCH A SOAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD ULTRA THIN KNITTED VASCULAR PROSTHESES COLLAGEN COATED ULTRA THIN KNITTED VASCULAR PROSTHESES DSY INTERVASCULAR, SAS IGKUT0007-70 99H20

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR VASCUTEK WOVEN VASCULAR PROSTHESIS 28 MM.